FDA 510(k) clearances — page 819
clearances on record, most recent first.
Clearances — page 819
81,801–81,900 of 176,637- K003711 — AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
- K003770 — BIRD TBIRD LEGACY VENTILATOR
- K003797 — ACE AIM TTC FUSION NAIL
- K000834 — CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO
- K002506 — BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
- K002989 — PROCLUDE
- K003178 — ELECSYS HCG AND BETA TEST SYSTEM
- K003228 — K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
- K003247 — CREATININE
- K993641 — METALYZER, MODEL 2; METALYZER, MODEL 3
- K994337 — VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
- K001233 — ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
- K001254 — ORTHOMATRIX, INC. CERCLAGE SYSTEM
- K002985 — ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
- K003016 — PRO-FEMUR R
- K003044 — COPELAND RESURFACING HEADS
- K003056 — OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
- K003067 — CALEO
- K003071 — GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K003144 — MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
- K003195 — GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
- K003241 — ECAT PET SCANNER
- K003283 — SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
- K003520 — NEXAN SYSTEM, MODEL NX-300
- K003523 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K003532 — HARDY DISK, CEFPODOXINE, 10MCG
- K003611 — PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
- K002411 — SHENLING ACUPUNCTURE NEEDLES
- K002569 — GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES
- K002899 — OPUS 20, MODEL 1ST
- K002970 — SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
- K003201 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- K003249 — PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228
- K003616 — COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
- K003660 — LEIBINGER NEURO CLIP SYSTEM
- K000249 — SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
- K000851 — PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
- K001160 — VERSABOND BONE CEMENT
- K001550 — EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM
- K001956 — TRIDENT ALL POLY CUP
- K002395 — MODEL 30 CLASSIC PNEUMATONOMETER
- K002616 — ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
- K002960 — TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
- K002996 — SYNERGY HA COATED POROUS FEMORAL STEMS
- K003078 — MERIT DRAINAGE DEPOT
- K003143 — MILLENNIUM BLADES, MODEL MB101
- K994146 — EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
- K002927 — SNARE,FLEXIBLE
- K000594 — LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
- K001669 — HANGER CRANIAL BAND
- K001895 — AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
- K002403 — NOVOFINE 31 DISPOSABLE NEEDLE
- K002614 — ADVENT IMPLANT SYSTEM
- K002691 — COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
- K002841 — COOL-TEC ELECTRODES
- K002845 — PAFLUFOCON C AND E DAILY CONTACT LENS
- K002868 — BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER
- K002951 — MAGELLAN VENTILATOR
- K002969 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
- K003002 — STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
- K003005 — TISSUELINK BIPOLAR FORCEPS
- K003169 — VASCULAR CLOSURE DEVICE
- K003183 — THERMAGE THERMACOOL II SYSTEM
- K003490 — OPUS ROD FIXATION SYSTEM
- K003674 — NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP
- K991613 — SW ULTRASOUND, MODELS 331, 311, 333
- K001866 — TCM400
- K002481 — ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
- K003448 — DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
- K003450 — INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
- K003452 — POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
- K001621 — DARDIK CAROTID SHUNT
- K001976 — STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
- K002135 — SLEEPSTRIP DISPOSABLE APNEA SCREENER
- K002232 — AEDEFIBRILLATOR
- K002794 — MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
- K002795 — MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
- K002798 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
- K003455 — MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
- K003469 — EECP THERAPY SYSTEM, MODEL TS3
- K003483 — MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
- K000582 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
- K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
- K002105 — SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
- K002128 — ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
- K002768 — ACAPELLA
- K002775 — DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
- K002782 — HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
- K002783 — FIXION INTERLOCKING NAIL (FIXION IL NAIL)
- K002894 — MEDIPRIME
- K003037 — JEWEL CAST III
- K003039 — GOLD CORE II
- K003141 — UBM PLUS, MODEL P45
- K003209 — URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
- K003291 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
- K003327 — ALBUMIN
- K003582 — FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
- K000846 — TKD SCALERS
- K001211 — MODIFICATION TO INTRALASE 600C LASER KERATOME
- K002224 — XPS 3000 SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.